ANDA 213592

CENTAUR PHARMS PVT

FDA Drug Application

Application #213592

Application Sponsors

ANDA 213592

CENTAUR PHARMS PVT

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	6.25MG	0	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
002	TABLET, EXTENDED RELEASE;ORAL	12.5MG	0	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-06-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-11-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CENTAUR PHARMS PVT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213592
            [companyName] => CENTAUR PHARMS PVT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"6.25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"12.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-04
        )

)